Clinical trial · Observational
Screening of Postoperative Pulmonary Complications by Electrical Impedance Tomography
Screening of Postoperative Pulmonary Complications by Electrical Impedance Tomography in Intensive Care Patients Undergoing Epigastric Surgery
NCT02337673CI-TRIAL-00070097completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine whether Electrical Impedance Tomography can be used as sensitive and specific predictor in the detection of postoperative pulmonary complications (e.g. pneumonia, bronchitis, acute respiratory distress syndrome, pleural effusion, pneumothorax, pulmonary edema, atelectasis, pulmonary embolism, hypoxemia, hypercapnia, spasms and obstructions of the airway) in patients undergoing epigastric surgery.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Diseases | — | UNRESOLVED | — |
| Malignant Neoplasm of Stomach | Malignant Gastric Neoplasm | ALIAS | 0.90 |
| Pancreatic Diseases | — | UNRESOLVED | — |
| Postoperative Respiratory Complications | — | UNRESOLVED | — |
| Pulmonary Disease | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Change of regional ventilation partition (ROI analysis in 8 pulmonary ROIs) from preoperative to postoperative state.
- timeFrame
- 1.) First EIT-measure: Preoperative Day; 2.) Second EIT-measure: Day of Operation (after extubation) or in between Postoperative Day 1-7 (in case of deferred extubation)
- description
- Comparison of the changed regional ventilation partition to the occurence of postoperative pulmonary complications =\> calculation of sensitivity and specifity of the primary outcome measure to predict PPC. Statistical analysis: receiver operating characteristic (ROC curve).
Secondary outcomes (6)
- measure
- Postoperative EIT-measured regional ventilation distribution (ROI analysis in 8 pulmonary ROIs)
- timeFrame
- 1 week
- description
- Sensitivity and specifiy for appearance of PPC (Postoperative Pulmonary Complications) within Postoperative Day 1-7. Statistical analysis: Sensitivity, Specificity, ROC-curve
- measure
- Postoperative EIT-measured regional ventilation distribution (ROI analysis in 8 pulmonary ROIs)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * age \> 17 years * no participation in another trial * mental and physical state allow written consent * elective epigastric surgery by laparotomy in general anesthesia (e.g. gastrectomy, splenectomy, pancreatic surgery, liver surgery/hemihepatectomy, cholecystectomy) Exclusion Criteria: * age \< 18 years * in women: pregnancy * missing or disability for giving written consent * emergency patients * patients after cardiac surgery less than 3 months ago * patients after pulmonary lobectomy during lifetime * patients with cardiac stimulator/defibrillator or any other implant with electric activity * patients with cutaneous lesions or bandage in the area of EIT electrode placement * patients with instability of the spine * body mass index \> 50
References
Publications (5)
- BACKGROUNDBodenstein M, David M, Markstaller K. Principles of electrical impedance tomography and its clinical application. Crit Care Med. 2009 Feb;37(2):713-24. doi: 10.1097/CCM.0b013e3181958d2f. PMID 19114889
- BACKGROUNDBodenstein M, Boehme S, Bierschock S, Vogt A, David M, Markstaller K. Determination of respiratory gas flow by electrical impedance tomography in an animal model of mechanical ventilation. BMC Pulm Med. 2014 Apr 29;14:73. doi: 10.1186/1471-2466-14-73. PMID 24779960
- BACKGROUNDHinz J, Neumann P, Dudykevych T, Andersson LG, Wrigge H, Burchardi H, Hedenstierna G. Regional ventilation by electrical impedance tomography: a comparison with ventilation scintigraphy in pigs. Chest. 2003 Jul;124(1):314-22. doi: 10.1378/chest.124.1.314. PMID 12853539
- BACKGROUNDRichard JC, Pouzot C, Gros A, Tourevieille C, Lebars D, Lavenne F, Frerichs I, Guerin C. Electrical impedance tomography compared to positron emission tomography for the measurement of regional lung ventilation: an experimental study. Crit Care. 2009;13(3):R82. doi: 10.1186/cc7900. Epub 2009 May 29. PMID 19480694
- BACKGROUNDVictorino JA, Borges JB, Okamoto VN, Matos GF, Tucci MR, Caramez MP, Tanaka H, Sipmann FS, Santos DC, Barbas CS, Carvalho CR, Amato MB. Imbalances in regional lung ventilation: a validation study on electrical impedance tomography. Am J Respir Crit Care Med. 2004 Apr 1;169(7):791-800. doi: 10.1164/rccm.200301-133OC. Epub 2003 Dec 23. PMID 14693669